Jade PTA Balloon Dilatation Catheter

K173894 · Orbusneich Medical Trading, Inc. · LIT · Feb 9, 2018 · Cardiovascular

Device Facts

• Record ID: K173894
• Device Name: Jade PTA Balloon Dilatation Catheter
• Applicant: Orbusneich Medical Trading, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Feb 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Jade PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.

Device Story

Rapid exchange balloon dilatation catheter for peripheral vasculature; used by physicians in clinical settings. Input: guidewire (max 0.014 inch) for coaxial guidance. Operation: catheter advanced to target lesion; balloon inflated via dilute contrast media injection through trailing hub to dilate vessels or stents. Features: minimally compliant balloon (1.5-6.0mm diameter; 15-120mm length); hydrophilic lubricious coating; platinum/iridium radiopaque marker bands for positioning; proximal shaft with female luer connector and stainless steel hypotube support. Output: mechanical dilation of obstructive lesions. Benefit: restores blood flow in peripheral arteries and dialysis fistulae; facilitates stent expansion.

Clinical Evidence

Bench testing only. Performance testing included dimensional verification, balloon preparation/deployment/retraction, rated burst pressure, fatigue, compliance, inflation/deflation time, bond strength, tip pull strength, flexibility, kinking, torque, radiopacity, coating integrity, particulate evaluation, and within-stent burst/fatigue. Biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility, pyrogenicity, and genotoxicity. All results met acceptance criteria.

Technological Characteristics

Rapid exchange balloon catheter; minimally compliant balloon material; rated burst pressure 18-20 atm; hydrophilic lubricious coating; stainless steel hypotube; platinum/iridium marker bands; nylon proximal shaft; 0.014 inch guidewire compatibility; 150cm working length.

Indications for Use

Indicated for patients requiring percutaneous transluminal angioplasty in peripheral vasculature (iliac, femoral, popliteal, infra-popliteal, renal arteries) or treatment of obstructive lesions in native/synthetic arteriovenous dialysis fistulae; also indicated for post-dilation of peripheral stents.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Sterling (K141150)

Reference Devices

• Sapphire NC Plus (K162209)
• NanoCross Elite (K141118)

Submission Summary (Full Text)

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February 9, 2018

OrbusNeich Medical Trading, Inc. Mr. John D. Pazienza Senior Director, Engineering 5363 NW 35th Avenue Fort Lauderdale, FL 33309

Re: K173894

Trade/Device Name: Jade PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: December 20, 2017 Received: December 21, 2017

Dear Mr. Pazienza:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Kenneth J. Cavanaugh -S

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K173894

Device Name Jade PTA Balloon Dilatation Catheter

#### Indications for Use (Describe)

The Jade PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg height="16" width="16"> <path d="M2 2 L14 14 M2 14 L14 2" stroke="black" stroke-width="2"></path> </svg> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" width="16"></rect> </svg> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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## 510(k) Summary

This 510(k) Summary is submitted in accordance with 21 CFR 807.92(c).

| Submitter: | OrbusNeich Medical Trading, Inc.<br>5363 NW 35th Avenue<br>Fort Lauderdale, FL 33309<br>Phone: [phone]<br>Fax: [phone] |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John D. Pazienza |
| Date Prepared: | February 8, 2018 |
| Trade Name: | Jade PTA Balloon Dilatation Catheter |
| Common Name: | Percutaneous Transluminal Angioplasty (PTA) Catheter |
| Classification Name: | Catheter, Angioplasty, Peripheral, Transluminal (21 CFR 870.1250,<br>Product Code LIT) |
| Predicate Device: | Sterling (K141150; cleared September 25, 2014) |
| Reference Devices: | Sapphire NC Plus (K162209; cleared October 6, 2016)<br>NanoCross Elite (K141118; cleared July 18, 2014) |
| Device Description: | The JADE Percutaneous Transluminal Angioplasty (PTA) Balloon<br>Dilatation Catheter is a rapid exchange balloon catheter for peripheral<br>indications with a working length of 150cm. The minimally compliant<br>balloons, available in diameters from 1.5-6.0mm and lengths from 15-<br>120mm, can be inflated by injecting dilute contrast media solution<br>through the trailing hub of the catheter. The balloon material is made<br>of a minimally compliant material with a rated burst pressure of 20 atm<br>( $Ø1.5-4.0mm$ ) or 18atm ( $Ø4.5-6.0mm$ ). Hydrophilic lubricious<br>coatings are applied to the distal section of the catheter. The proximal<br>shaft of the catheter is composed of a female luer connector bonded to<br>a nylon tube which is internally supported by a stainless steel<br>hypotube. Two radiopaque platinum/iridium marker bands are located<br>within the balloon shoulders. The internal lumen of the catheter<br>accepts a maximum 0.014 inch (0.36mm) guidewire. The guidewire<br>enters the catheter tip and advances coaxially out the RX port, thereby<br>allowing both coaxial guidance and rapid exchange of catheter with a<br>single standard length guidewire. Two marked sections, 3mm in<br>length located on the proximal shaft specifically designed to be highly<br>visible, indicate catheter position relative to the guiding catheter or<br>guiding sheath. The design of this dilatation catheter does not<br>incorporate a lumen for distal dye injections or distal pressure<br>measurements. |

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- Intended Use: The Jade PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.
- Technological Characteristics: Comparisons of the new and predicate devices show that the technological characteristics such as product performance, design, and intended use are substantially equivalent to the currently marketed predicate devices.
- Performance Data: Both in vitro performance tests, such as dimensional verification, balloon preparation, deployment, and retraction, balloon rated burst pressure, balloon fatigue, balloon compliance, balloon inflation and deflation time, catheter bond strength, tip pull strength, flexibility and kinking, torque strength, radiopacity, coating integrity, particulate evaluation, within stent balloon burst strength, and within stent balloon fatigue and also biocompatibility tests, such as cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility (hemolysis, partial thromboplastin time, platelet and leukocyte counts, complement activation, and in vivo thromboresistance). pyrogenicity. and genotoxicity (bacterial mutagenicity and in vitro mouse lymphoma) were conducted on the Jade PTA balloon dilatation catheter. The test results met all acceptance criteria, were similar to predicate devices, and ensure that the Jade PTA balloon dilatation catheter design and construction are suitable for its intended use.
- This information supports a determination of substantial equivalence Conclusion: between the Jade PTA balloon dilatation catheter and the predicate device described above.